Eating BehaviorNCT05773625
JITAIs: Optimization of Effectiveness
A study testing Just-In-Time Adaptive Intervention in people with Eating Behavior and Chronic Disease, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
The goal of this feasibility study is to get insight into the receptivity of a JITAI aimed at healthy dietary intake in inhabitants of a small city in the Netherlands. The main question it aims to answer is: what is the right time and the right location to send notifications to people and for what type of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Chronic Disease
- What is being tested?
- Just-In-Time Adaptive Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Open or motivated to improve their eating behaviour (as this is the target group of the final developed app)
- Older than 18 years old
- Living in Wageningen
- Is able to understand and speak Dutch
- Having an Android phone
Who cannot join
- Does not have a specific goal to improve eating behaviour
- Is under 18 years old
- Does not live in Wageningen
- Does not speak and/or understand Dutch
- Does not have an android phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring, Analyzing and Mapping Environmental Influences on (and Changes in) Spatial Patterns: Evidence for Just-in-time Adaptive Interventions
The goal of this feasibility study is to get insight into the receptivity of a JITAI aimed at healthy dietary intake in inhabitants of a small city in the Netherlands.
The main question it aims to answer is:
- what is the right time and the right location to send notifications to people and for what type of interventions are people most receptive? Furthermore, the aim is to get insight into the relevance and usability of the app, the privacy concerns that people have and the perceived effectiveness of the app on dietary intake.
Participants will test our app for 2 weeks, of which they will receive prompts during one week.
Read the detailed description
JITAIs have already been developed in the fields of physical activity, smoking, alcohol use and mental illness. Within these fields, results were promising since JITAIs have proven to be effective in changing behaviour. Until now, no JITAIs have been developed that primarily focus on eating behaviour and it is expected that this type of interventions yields great potential in changing eating behaviour.
In this feasibility study a newly developed app is tested with the aim to get insight into what factors influence the receptiveness of people. Receptiveness is the person's ability to receive, process, and use the support provided, which is a prerequisite to achieve behaviour change. In the pilot study the aim is to investigate when and where the right time is to send notifications to people and for what type of interventions people are most receptive.
Participants are inhabitants of Wageningen who will test our app for 2 weeks. In the first week nothing is expected from the participants, but their movement patterns are collected via GPS; the participants are their own control for the Just-In-Time principle. In the second week the participants receive notifications (i.e., a healthy recipe, a tip for the healthier option at a certain location) based on their selected goal (eating more vegetables, eating less meat, less unhealthy snacking). After receiving the notification, participants are asked to answer several questions. At the end of the day, participants are asked to give us more insight in what they like and dislike to receive, at which locations, at what times, how many times a day, and their reasons behind this.
With this data the app can be further developed (co-creation).
The results of the study will be analysed within persons to visualize patterns. A second goal is to test if the movement patterns of participants can be used to objectively measure if interventions are effective in the future. The movement patterns will be analysed with the use of different algorithms, to see if and how movement patterns can say anything about the behaviour of people (stopping, standing still, alter routes). The movement patterns can be linked to received interventions, locations and receptivity.
Within this pilot study, people are not asked to alter their behaviour. Participants do receive notifications that are focused on making healthier eating choices, but the expectation is that this will not lead to behavioural changes within one week. The goal of the study is to get better insight into the best way to respond to the Just-In-Time principle. Participants will receive zero to several notifications a day for a period of 1 week.
- Conditions
- Eating Behavior, Chronic Disease
- Being tested
- Just-In-Time Adaptive Intervention
- Medical subject headings
- Feeding Behavior, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just-In-Time Adaptive InterventionDevice
Participants will be exposed to a new innovative app to test.
| Study group | Role | What they receive |
|---|---|---|
| Test group of app | Other | All participants will first use the app one week without receiving just-in-time notifications. Their movement patterns are collected through GPS. In the second week, they will receive just-in-time notifications based on their chosen goal. Participants will act as their own control group. Receives: Device: Just-In-Time Adaptive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptivity
The receptiveness is measured with short questions after each prompt on whether the prompt is opportune. Questions on receptiveness are send after every prompt during one week (second week of the study). Dependent on how many locations people visit at which they receive a prompt.
Measured: Receptivity is measured during one week, after every prompt
Secondary outcomes (1)
Movement patterns
Movement patterns are collected within the city of Wageningen using GPS.
Measured: Location is stored every 5 seconds during two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Dr. Laura H.H. Winkens, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773625
- Sponsor's protocol ID
- 555003027
- Status last verified
- Dec 2023
- First submitted
- 12 Jan 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winkens LH, Sonneveld NA, Ligtenberg A, Schwarz A, Simons M. Exploring the Receptivity and Feasibility of Just-In-Time Support for Healthy Food Choices: Mixed-Method Insights for Adaptive Intervention Development. Curr Dev Nutr. 2026 Jun 6;10(7):109391. doi: 10.1016/j.cdnut.2026.109391. eCollection 2026 Jul.
PubMed 42396594
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring, Analyzing and Mapping Environmental Influences on (and Changes in) Spatial Patterns: Evidence for Just-in-time Adaptive Interventions
- ClinicalTrials.gov ID
- NCT05773625
- Acronym / sponsor ID
- 555003027
- Conditions
- Eating Behavior, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this feasibility study is to get insight into the receptivity of a JITAI aimed at healthy dietary intake in inhabitants of a small city in the Netherlands.
The main question it aims to answer is:
- what is the right time and the right location to send notifications to people and for what type of interventions are people most receptive? Furthermore, the aim is to get insight into the relevance and usability of the app, the privacy concerns that people have and the perceived effectiveness of the app on dietary intake.
Participants will test our app for 2 weeks, of which they will receive prompts during one week.
Detailed description
JITAIs have already been developed in the fields of physical activity, smoking, alcohol use and mental illness. Within these fields, results were promising since JITAIs have proven to be effective in changing behaviour. Until now, no JITAIs have been developed that primarily focus on eating behaviour and it is expected that this type of interventions yields great potential in changing eating behaviour.
In this feasibility study a newly developed app is tested with the aim to get insight into what factors influence the receptiveness of people. Receptiveness is the person's ability to receive, process, and use the support provided, which is a prerequisite to achieve behaviour change. In the pilot study the aim is to investigate when and where the right time is to send notifications to people and for what type of interventions people are most receptive.
Participants are inhabitants of Wageningen who will test our app for 2 weeks. In the first week nothing is expected from the participants, but their movement patterns are collected via GPS; the participants are their own control for the Just-In-Time principle. In the second week the participants receive notifications (i.e., a healthy recipe, a tip for the healthier option at a certain location) based on their selected goal (eating more vegetables, eating less meat, less unhealthy snacking). After receiving the notification, participants are asked to answer several questions. At the end of the day, participants are asked to give us more insight in what they like and dislike to receive, at which locations, at what times, how many times a day, and their reasons behind this.
With this data the app can be further developed (co-creation).
The results of the study will be analysed within persons to visualize patterns. A second goal is to test if the movement patterns of participants can be used to objectively measure if interventions are effective in the future. The movement patterns will be analysed with the use of different algorithms, to see if and how movement patterns can say anything about the behaviour of people (stopping, standing still, alter routes). The movement patterns can be linked to received interventions, locations and receptivity.
Within this pilot study, people are not asked to alter their behaviour. Participants do receive notifications that are focused on making healthier eating choices, but the expectation is that this will not lead to behavioural changes within one week. The goal of the study is to get better insight into the best way to respond to the Just-In-Time principle. Participants will receive zero to several notifications a day for a period of 1 week.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group of app | Other | Device: Just-In-Time Adaptive InterventionAll participants will first use the app one week without receiving just-in-time notifications. Their movement patterns are collected through GPS. In the second week, they will receive just-in-time notifications based on their chosen goal. Participants will act as their own control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Open or motivated to improve their eating behaviour (as this is the target group of the final developed app)
Key exclusion criteria (5 listed)
- Does not have a specific goal to improve eating behaviour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Just-In-Time Adaptive InterventionParticipants will be exposed to a new innovative app to test. | Device | Test group of app |
Primary outcome
Receptivity
Time frame: Receptivity is measured during one week, after every prompt
The receptiveness is measured with short questions after each prompt on whether the prompt is opportune. Questions on receptiveness are send after every prompt during one week (second week of the study). Dependent on how many locations people visit at which they receive a prompt.
1 secondary outcome
Movement patterns
Time frame: Location is stored every 5 seconds during two weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 42396594Winkens LH, Sonneveld NA, Ligtenberg A, Schwarz A, Simons M. Exploring the Receptivity and Feasibility of Just-In-Time Support for Healthy Food Choices: Mixed-Method Insights for Adaptive Intervention Development. Curr Dev Nutr. 2026 Jun 6;10(7):109391. doi: 10.1016/j.cdnut.2026.109391. eCollection 2026 Jul.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Just-In-Time Adaptive Intervention in people with Eating Behavior and Chronic Disease, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receptivity (time frame: Receptivity is measured during one week, after every prompt). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05773625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.